The American Society for Microbiology (ASM) appreciates the opportunity to review and comment on specific components of CMS-1533-P, Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, published in the Federal Register, Volume 72, Number 85 on May 3, 2007. The ASM is the largest, single life sciences society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical laboratory fields.

Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating the performance of new technologies. Clinical microbiologists, in particular, are involved on a day-to-day basis with the etiologic diagnosis of infectious diseases, including hospital-acquired infections. Therefore, ASM members have a significant interest in ensuring that any revisions to the Inpatient Prospective Payment System acknowledge the importance and the complexities of establishing a microbiologic diagnosis, particularly if such data are to be used as a basis for payment adjustment.

The ASM will focus its comments on Section II.F. DRGs: Hospital-Acquired Conditions:

The diagnosis of a hospital acquired infection is a complex process based in part on clinical signs and symptoms as assessed by a physician relative to the time of a patient’s admission. By definition, the infection will not have been present or incubating at the time of admission, but will manifest clinically at some variable point during treatment for another condition.

During the hospital course, if the medical condition of the patient dictates that they require an intervention (e.g. urinary catheter or a vascular access device), then it is a standard of care that the ordering physician has discussed the use of these interventions with the patient or authorized patient representative. Use of devices such as urinary catheters and vascular access devices would have to meet the requirements of being both reasonable and necessary, but they would also carry a risk of secondary infection. Measures to reduce this risk can and should be taken, and can also, in fact, be reasonably monitored through Infection Control Quality Indicators (such Quality Indicators being described in Section IVA, “Quality Indicators”). However, it is virtually impossible to reduce the risk to zero, and financial penalties for having used a necessary intervention leading to an infection are unreasonable.

However, equally important is the specific etiologic diagnosis, based on data generated by the microbiology laboratory by a variety of techniques, both traditional culture based as well as newer molecular tests. While accepted patient care guidelines are in place to minimize the occurrence of various hospital acquired infections as cited in this document, guidelines which define these infections both in terms of clinical presentation as well as based on microbiologic data are not standardized. In particular, microbiologic methods show a marked degree of heterogeneity with regard to both methods employed as well as determination of clinical significance of isolates, both factors which can affect the accuracy of a microbiologic diagnosis of a given infection. Further, recent trends towards decentralization of laboratories introduce additional preanalytical variables which may be a significant confounding factor in establishing an accurate etiologic diagnosis. With this is mind, we urge CMS to consider the need to establish specific microbiologic parameters prior to implementing any hospital acquired infection as a condition for DRG payment adjustment. As an example, for the National Nosocomial Infection Survey (NNIS), both clinical and laboratory guidelines have been established for diagnosis of nosocomial pneumonia (see: http://www.cdc.gov/ncidod/hip/NNIS/members/pneumonia/Final/PneumoCriteriaV1.pdf)

With regard to the specific conditions proposed for implementation:

(a) Catheter associated urinary tract infections:

ASM does not support the proposal that this be selected as one of the initial hospital acquired conditions. While we agree that the condition meets the established criteria, there are currently no widely accepted guidelines that define microbiologic diagnosis for this condition. The prevention guidelines cited from 1981 do not include laboratory parameters necessary for establishing diagnosis. However, at least two professional society documents are forthcoming that may help in establishing such criteria. The ASM Cumitech series has an updated edition of the document on Diagnosis of Urinary Tract Infections under review, and the Infectious Diseases Society of America has a planned document on Catheter-associated Urinary Tract Infections in progress for Spring 2008 release. Until a standard microbiologic definition with a defined threshold for clinical significance and delineation of expected uropathogens is established, we believe there exists significant risk for variability in establishing and coding for a catheter associated urinary tract infection. Our recommendation is to withhold this from consideration until such criteria are developed.

(f) Staphylococcus aureus septicemia:

ASM does not support the proposal that this be selected as one of the initial hospital acquired conditions. While we agree that vascular catheter associated infections meet the criteria for selection, we also agree that coding is problematic and support the decision not to include this general category in the initial selection process. Further, as previously noted, there is a lack of a consensus document on how to reliably establish a vascular catheter associated infection, including any caused by S. aureus.

These same concerns apply to any attempt to single out bloodstream infection with any particular pathogen as a preventable condition. While exclusions are noted for concomitant diagnosis of pneumonia, S. aureus is a pathogen of many anatomic sites and concomitant bloodstream infection may accompany infection at sites other than the lungs. With the recent emergence of serious skin and soft tissue infections due to methicillin resistant S. aureus, as well as the propensity of the organism to disseminate via the vasculature to establish secondary abscesses at other locations, we believe it is impossible to clearly define a S. aureus bloodstream infection as strictly hospital acquired. Further, as a subset of individuals are known to be stably colonized with S. aureus, absent any mandatory effort to perform preadmission testing and possibly decolonization for this organism, hospital acquired infection with this organism, including septicemia, may not be entirely preventable. In other words, colonization with S. aureus may actually represent a condition “POA” (present on admission) that is a risk factor for hospital acquired infection, and bloodstream infection may be due, in part, to patient-related factors beyond the control of the health care worker. Consensus guidelines for managing MRSA colonization do not currently exist.

Other hospital acquired infections:

For other hospital acquired infections not currently proposed for inclusion due primarily to coding concerns (i.e. ventilator associated pneumonia, vascular associated infections, C. difficile disease, MRSA infection, and surgical site infection), we echo our previous general concern. Until consensus guidelines are developed and accepted for the microbiologic assessment and etiologic diagnosis of these conditions, we have significant concerns that accurate diagnosis of the conditions may be compromised. This could lead to an inappropriate DRG adjustment.

CMS-1533-P is a highly complex document, and the time frame for developing comments was limited. Therefore, should you require any additional supporting information with regard to the ASM recommendations, please do not hesitate to contact the Society. In addition, should you require assistance or input into developing consensus microbiologic procedural guidelines, we stand ready to cooperate in any way possible.